【ChiCTR-TRC-07000706】A Multi-centre, Randomized, Controlled Study of External Counterpulsation for Patients with Recent Atherosclerotic Stroke

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基本信息

登记号

ChiCTR-TRC-07000706

试验状态

正在进行

药物名称

药物类型

规范名称

首次公示信息日的期

2007-11-21

临床申请受理号

靶点

适应症

Ischemic Stroke

试验通俗题目

A Multi-centre, Randomized, Controlled Study of External Counterpulsation for Patients with Recent Atherosclerotic Stroke

试验专业题目

A Multi-centre, Randomized, Controlled Study of External Counterpulsation for Patients with Recent Atherosclerotic Stroke

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临床试验信息

试验目的

To determine the effect of External Counterpulsation for Patients with Recent Atherosclerotic Stroke. It uses sequential air cuffs filling in the calf, thigh and buttock to enhance diastolic pressure. It has been approved for the treatment of refractory angina worldwide. Its mechanism of action is thought to be diversion of blood from the lower extremities to the heart and brain and also promote collateral. In this proposal, we aim to confirm the efficacy and safety of external counterpulsation for the treatment of stroke patients with ischemic of atherosclerotic origin. Patients will be randomized to receive 35 one-hour sessions of ECP or no ECP, in addition to best available evidence-based medical and rehabilitation treatment.Neurological deficit, disability, recurrent events and safety will be documented on randomisation and 12 weeks after stroke onset.

试验分类

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试验类型

随机平行对照

试验分期

Ⅰ期

随机化

random

盲法

试验项目经费来源

CUHK Neurology Fund

试验范围

目标入组人数

250

实际入组人数

第一例入组时间

2007-05-01

试验终止时间

1990-01-01

是否属于一致性

入选标准

1) Subject is aged not less than 18; 2) Subject is presented with clinical diagnosis of ischaemic stroke according to the WHO criteria; 3) Recent ischemic stroke is within 7 days of symptom onset; 4) Subject is found to have motor deficit as a result of stroke; 5) Subject has brain CT performed and results confirmed no evidence of intracerebral haemorrhage; 6) NIHSS is between 4 and 16 inclusive; 7) Pre-stroke mRS 0-1; 8) Evidence of large artery occlusive disease. If no diagnostic procedure is done before randomization, neuroimaging should be done within 3 days of randomisaton; 9) Subject or his/her legally acceptable representative is willing to provide written informed consent.；

排除标准

1) Subject is aged less than 18; 2) Subject has evidence for cardioembolic stroke such as atrial fibrillation and rheumatic heart disease; 3) Subject has evidence for haemorrhage on brain CT; 4) Subject has a history of intracerebral haemorrhage; 5) Subject has evidence for AVMs, AV fistula or aneurysm; 6) Subject has active malignancy; 7) Subject has no definite motor deficit; 8) Subject has a National Institutes of Health Stroke Scale (NIHSS) of less than 4 or greater than 16; 9) Subject has sustained hypertension (systolic >180mmHg or diastolic >100mmHg); 10) Subject is unlikely to be followed up at Week 12; 11) Subject has co-existing systemic diseases: renal failure (creatinine >300 umol/L, if known), cirrhosis, severe dementia or psychosis; 12) Subject has brain tumour or other significant non-ischaemic brain lesion on CT; 13) Subject has thrombocytopenia (platelet count<100,000/mm3, if known); 14) Subject is a pregnant female, a breast-feeding mother, is planning pregnancy during the course of the trial or has a positive urine pregnancy test immediately prior to randomisation; 15) Subject is participating in another clinical trial within 30 days before randomisation; 16) Subject or his/her legally acceptable representative is unwilling to provide written informed consent.；

研究者信息

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试验机构

Division of Neurology, Department of Medicine & Therapeutics, CUHK

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